Access and Dissector System - India CDSCO Medical Device Registration

Access and Dissector System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000215_e678aaa4792bc654a2cb074a12380f5b_be6d0e33e6d1a096338e34dbca095892. This device is marketed under the brand name Endo Shears™ Auto Suture™ Shears. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class B

Access and Dissector System

UID: IMP/MD/2018/000215_e678aaa4792bc654a2cb074a12380f5b_be6d0e33e6d1a096338e34dbca095892

Brand Name

Endo Shears™ Auto Suture™ Shears

License Holder

India Medtronic Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Spacemaker Pro dissection balloon is primarily indicated for patients undergoing laparoscopic surgery requiring tissue separation of the extraperitoneal space. The Spacemaker Pro blunt tip trocar is intended for use in establishing a port of access for insertion of endoscopic instruments into the abdominal cavity or extraperitoneal space in abdominal and extraperitoneal surgery. The Spacemaker™ Pro structural balloon trocar is primarily indicated for patients undergoing laparoscopic surgical procedures requiring a sealed port of access and/or tissue retraction. This is also indicated in patients undergoing laparoscopic surgery requiring a sealed port of access and/or tissue separation in extraperitoneal procedures, such as in hernia repair, lymphadenectomy or bladder neck suspension procedures.